The present invention is directed to an apparatus for separating unwanted debris from stoppers utilizing a novel vacuum separator system.
During the process of manufacturing and packaging pharmaceutical compositions, particularly of a powder form, measured amounts of the compositions may be placed into sterilized bottles, followed by sealing the bottles with sterilized rubber stoppers, and placing tamper-evident labels over the stoppers.
The packaging components, i.e. bottles and stoppers, must be washed and sterilized prior to entering the process. Typically, the rubber stoppers are purchased new from intravenous (IV) stopper manufactures. While the manufacturers may represent the stoppers to be free of unwanted material and debris, it has been found that lint, hairs, fibers, etc. may be associated therewith. After bottle sealing and upon final inspection, if debris is found in packaged products, the bottles are rejected and the product is destroyed. Debris contained within sterilized, pharmaceutical products typically result in the loss of products and revenue.
To ensure that IV stopper are free of debris, a novel stopper vacuuming step may be introduced into stopper preparation process. Prior to washing and sterilizing the stoppers, they may be placed into a debris separator to ensure that any unwanted, extraneous material is removed prior to the washing step.
It has now been discovered that vacuuming the stoppers prior to utilizing them in the packaging process is beneficial to remove all unwanted matter and debris therefrom. To accomplish this feat, a novel stopper debris separator is described herein.
The present invention is directed to an apparatus for separating dirt and unwanted debris from stoppers, particularly IV stoppers. While other uses of the apparatus of the present invention will become apparent to those skilled in the art, the present invention is more particularly directed to an apparatus for removing fine particles of unwanted debris from surfaces and voids of rubbery-type stoppers.
The stopper debris separator of the present invention, generally, may be characterized by:
a) a stopper injection hopper of suitable volume for receiving a plurality of debris-containing stoppers;
b) a stopper inlet duct having first and second ends, the first end for receiving stoppers from the stopper injection hopper;
c) a vertically-positioned, cyclone separator tube having first and second ends, and a stopper receiving duct positioned proximate and adjacent to the first end of the cyclone separator, the second end of the stopper inlet duct connected to the stopper receiving duct, the cyclone separator tube being of sufficient diameter for receiving stoppers from the inlet duct;
d) a stopper receiving vessel, positioned beneath and connected to the first end of the cyclone separator tube, the vessel being of sufficient capacity to receive a plurality of stoppers from the separator tube;
e) an air bleeding valve located on the receiving vessel, the valve being suitable for adjusting the vacuum pressure on the separator;
f) a vacuum pump having an inlet and outlet for transferring air, a filter for collecting debris, and a vacuum inlet;
g) a vacuum duct having first and second ends, the first end connected to the second end of the cyclone separator tube, and the second end connected to the vacuum inlet of the vacuum pump; and
h) means for transferring air through the inlet and outlet of the vacuum pump to create a vacuum within the separator,
wherein, debris-containing stoppers in the stopper injection hopper are drawn through the stopper duct into the cyclone separator tube by the vacuum, wherein the debris on the stoppers is separated therefrom and drawn through the vacuum duct into the vacuum filter to produce clean stoppers, and wherein the clean stoppers drop into the stopper receiving vessel.